Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT02921334
Status:
UNKNOWN
Last Update Posted:
2016-10-03
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-09-29', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ventilator weaning days', 'timeFrame': 'from enrollment to 90 days'}], 'secondaryOutcomes': [{'measure': 'successful weaning rate', 'timeFrame': 'from enrollment to 90 days'}, {'measure': 'ICU stay days', 'timeFrame': 'from admission to 90 days'}, {'measure': 'hospital stay days', 'timeFrame': 'from admission to 90 days'}, {'measure': 'ICU mortality', 'timeFrame': 'from admission to 90 days'}, {'measure': 'hospital mortality', 'timeFrame': 'from admission to 90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventilator Weaning']}, 'descriptionModule': {'briefSummary': 'The aim of this study is early tracheotomy to facilitate weaning by switching between invasive and noninvasive ventilation.', 'detailedDescription': 'When a patient is eligible to this study, he or she is randomly assigned to intervention or control group.In intervention group,tracheotomy is performed. And then, patient is switched to noninvasive ventilation by masking the tracheotomy tube. If the patient presents distress in noninvasive ventilation, he or she is switched to invasive ventilation. If the distress relieves, patient is switched to noninvasive ventilation again until the patient successfully weans from ventilator. In control group, the patient is weaned as the conventional methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* duration of invasive ventilation 5 to 7 days\n* anticipation of difficult weaning\n* Glasgow Coma Scale ≥13\n* no upper airway obstruction\n* presence of spontaneous breath\n\nExclusion Criteria:\n\n* age less than 18 or more than 85 years;\n* contraindications for noninvasive ventilation;\n* anticipation of survival less than 6 months;\n* refusal of tracheotomy'}, 'identificationModule': {'nctId': 'NCT02921334', 'briefTitle': 'Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Efficacy and Safety of Early Tracheotomy for Switching Between Invasive and Noninvasive Ventilation to Facilitate Weaning: a Randomized Control Trial', 'orgStudyIdInfo': {'id': 'cqykdxfsdyyy3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patients in this group are received ventilator weaning by switching between invasive and noninvasive ventilation.', 'interventionNames': ['Procedure: switching between invasive and noninvasive ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients in this group are weaned from ventilator as conventional methods.'}], 'interventions': [{'name': 'switching between invasive and noninvasive ventilation', 'type': 'PROCEDURE', 'description': 'As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Duan', 'role': 'CONTACT', 'email': 'duanjun412589@163.com', 'phone': '86-023-89012680'}], 'facility': 'The first affiated hospital, chongqing medical university', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Guosheng Ren, MD', 'role': 'CONTACT', 'phone': '02389012680'}], 'overallOfficials': [{'name': 'Shuliang Guo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Duan jun', 'investigatorAffiliation': 'Chongqing Medical University'}}}}